Fluoride Varnish Randomized Clinical Trial

NCT00066963 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 376

Last updated 2022-03-09

Study results available
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Summary

The purpose of this study is to compare the efficacy of fluoride varnish (FV) applied once or twice a year with counseling to counseling alone in preventing early childhood caries (ECC) (tooth decay in children under the age of five).

Conditions

  • Dental Caries

Interventions

DEVICE

Fluoride Varnish

0.1 mL (1 drop) applied on each of 2 arches

Sponsors & Collaborators

Principal Investigators

  • Jane A Weintraub, DDS, MPH · University of California, San Francisco (now Univ North Carolina)

  • Francisco Ramos-Gomez, DDS, MPH · University of California, San Francisco (now Univ Calif Los Angeles)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
36 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2002-10-31
Primary Completion
2006-11-30
Completion
2006-12-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00066963 on ClinicalTrials.gov